Study of the Safety and Efficacy of Two Fixed Doses of OPC-34712 as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder (the Polaris Trial)

Otsuka

Status and phase: Completed; Phase 3

Conditions: Mental Disorders; Depressive Disorder, Major; Depression; Mood Disorders; Depressive Disorder

Treatments: Drug: Placebo + ADT; Drug: OPC-34712 + ADT

Study type: Interventional

Funder types: Industry

Identifiers

NCT01360632

331-10-227

Details and patient eligibility

About

To compare the effect of OPC-34712 (brexpiprazole) to the effect of placebo (an inactive substance) as add on treatment to an assigned FDA approved antidepressant treatment (ADT) in patients with Major Depressive Disorder who demonstrate an incomplete response to a prospective trial of the same assigned FDA approved ADT

Enrollment: 1,539 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female subjects between 18 and 65 years of age, with diagnosis of major depressive disorder, as defined by DSM-IV-TR criteria
• The current depressive episode must be equal to or greater than 8 weeks in duration
• Subjects must report a history for the current depressive episode of an inadequate response to no more than three adequate antidepressant treatments

Exclusion criteria

• Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving study drug
• Subjects who report an inadequate response to more than three adequate trials of antidepressant treatments during current depressive episode at a therapeutic dose for an adequate duration
• Subjects with a current Axis I (DSM-IV-TR) diagnosis of: Delirium, dementia, amnestic or other cognitive disorder, Schizophrenia, schizoaffective disorder, or other psychotic disorder, Bipolar I or II disorder
• Subjects with a clinically significant current Axis II (DSM-IV-TR) diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal or histrionic personality disorder

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,539 participants in 2 patient groups, including a placebo group

Phase B

Experimental group

Description:

Drug: OPC-34712 + ADT Drug: Placebo + ADT

Treatment:

Drug: Placebo + ADT

Drug: OPC-34712 + ADT

Drug: Placebo + ADT

Phase A

Placebo Comparator group

Description:

Drug: Placebo + ADT

Treatment:

Drug: Placebo + ADT

Drug: Placebo + ADT